Financial Incentives to Translate ALLHAT Into Practice: A Randomized Trial

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ClinicalTrials.gov Identifier: NCT00302718

Recruitment Status : Completed

First Posted : March 14, 2006

Results First Posted : December 15, 2014

Last Update Posted : January 30, 2019

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Sponsor:

Collaborator:

National Heart, Lung, and Blood Institute (NHLBI)

Information provided by (Responsible Party):

VA Office of Research and Development

Study Description

Brief Summary:

The purpose of this study was to determine whether financial incentives for guideline-recommended treatment of hypertension are effective. We hypothesized that patients with hypertension cared for by physicians or practice groups receiving financial incentives were more likely to be prescribed guideline-recommended anti-hypertensive medications and achieve Joint National Commission (JNC) 7 guideline-recommended blood pressure goals compared to patients who were treated by providers that did not receive financial incentives.

Condition or disease	Intervention/treatment	Phase
Hypertension	Behavioral: Physician-level financial incentives Behavioral: Practice-level financial incentives Behavioral: Physician- and practice-level financial incentives	Not Applicable

Detailed Description:

Background:

Despite compelling evidence of the benefits of treatment, hypertension is controlled in less than one-quarter of US citizens. Using a cluster randomized controlled trial, we tested the effect of explicit physician-level and practice-level financial incentives to promote the provision of guideline-recommended anti-hypertensive medications and improved control of hypertension in the VA primary care setting.

Objectives:

The goals were to: (1) determine the effect of physician-level financial incentives on processes and outcomes of care for outpatients with hypertension; (2) assess the impact of practice-level incentives; (3) ascertain whether there were additive or synergistic effects of physician- and practice-level incentives; (4) evaluate the persistence of the effect of incentives after the intervention ceases; and (5) identify any negative impacts of incentives on patients, providers, or health care organizations.

Methods:

We randomized 12 VA hospital-based outpatient clinics to the following arms: (1) physician-level incentives; (2) practice-level incentives; (3) physician- and practice-level incentives; and (4) no incentives. We enrolled 83 primary care physicians and 42 practice group members (e.g., nurses). All participants received audit and feedback performance reports. Study measures included the use of guideline-recommended anti-hypertensive medications and the proportion of patients who achieved national (JNC 7) guideline-recommended blood pressure goals or received an appropriate response to uncontrolled blood pressure. The intervention period consisted of five four-month performance periods. For each period, trained reviewers collected medications, blood pressure readings, comorbid conditions, medication allergies, and lifestyle recommendations from the VA electronic health record system for a sample of eligible patients from the physicians' panels. After the final performance report, we implemented a 12-month washout period. To determine the impact of incentives for the intervention period, we performed a repeated-measures longitudinal analysis using the hospital as a random effect. We evaluated the rate of change in the proportion of patients who met the study measures over time for the intervention group physicians. We assessed post-washout performance using a linear analysis with clustering by hospital. To evaluate unintended consequences of the incentives, we examined the incidence of hypotension in the physicians' panels.

Status:

The study is completed. The primary findings were published in September 2013 in the Journal of the American Medical Association (JAMA). We are currently preparing manuscripts describing findings from the study's secondary aims.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	83 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Health Services Research
Official Title:	RCT of Financial Incentives to Translate ALLHAT Into Practice
Study Start Date :	February 2007
Actual Primary Completion Date :	October 2011
Actual Study Completion Date :	September 2012

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Hypertension

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Physician-level incentives Examines the effect of physician-level financial incentives on hypertension quality of care	Behavioral: Physician-level financial incentives Enrolled physician participants are eligible to receive financial incentives and audit and feedback reports based on their performance during a 4-month interval on the hypertension care study outcomes.
Experimental: Practice-level incentives Examines the effect of practice-level financial incentives on hypertension quality of care	Behavioral: Practice-level financial incentives Enrolled practices (physician physicians and non-physician primary care personnel) are eligible to receive financial incentives and audit and feedback reports based on the performance of the practice during a 4-month interval on the hypertension care study outcomes.
Experimental: Physician- and practice-level incentives Examines the effect of physician- and practice-level financial incentives on hypertension quality of care	Behavioral: Physician- and practice-level financial incentives Enrolled participants are eligible to receive financial incentives and audit and feedback reports based on performance during a 4-month interval on the hypertension care study outcomes. This arm tests the effect of combined financial incentives (physician-level incentives and practice-level incentives).
No Intervention: No incentives (control) Physician participants in this arm received only audit and feedback performance reports as did the participants in the intervention arms.

Outcome Measures

Primary Outcome Measures :

Proportion of the Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure [ Time Frame: Baseline period (August-November 2007) ]
This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the first performance period (baseline). Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the guidelines from the "Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7)" to determine if the physicians' patients achieved the recommended blood pressures thresholds and if providers appropriately responded to uncontrolled blood pressure. Appropriate responses included increasing the dosage of a guideline-recommended antihypertensive medication or recommending a lifestyle modification to patient with Stage 1 hypertension.
Proportion of Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure [ Time Frame: Final intervention period (April-July 2009) ]
This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the fifth and final intervention performance period. Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the guidelines from the "Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7)" to determine if the physicians' patients achieved the recommended blood pressures thresholds and if providers appropriately responded to uncontrolled blood pressure. Appropriate responses included increasing the dosage of a guideline-recommended antihypertensive medication or recommending a lifestyle modification to patient with Stage 1 hypertension.
Proportion of Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure [ Time Frame: After the washout period (May-August 2011) ]
This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the post-washout performance period. Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the guidelines from the "Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7)" to determine if the physicians' patients achieved the recommended blood pressures thresholds and if providers appropriately responded to uncontrolled blood pressure. Appropriate responses included increasing the dosage of a guideline-recommended antihypertensive medication or recommending a lifestyle modification to patient with Stage 1 hypertension.
Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications [ Time Frame: Baseline period (August-November 2007) ]
This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the first performance period (baseline). Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the "Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7)" to evaluate use of guideline-recommended antihypertensive medications. Assessing use of guideline-recommended medications included collecting information about the patient's compelling conditions (e.g., diabetes mellitus) as well as allergies and refusals to antihypertensive medications.
Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications [ Time Frame: Final intervention period (April-July 2009) ]
This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the fifth and final intervention performance period. Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the "Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7)" to evaluate use of guideline-recommended antihypertensive medications. Assessing use of guideline-recommended medications included collecting information about the patient's compelling conditions (e.g., diabetes mellitus) as well as allergies and refusals to antihypertensive medications.
Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications [ Time Frame: After the washout period (May-August 2011) ]
This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the post-washout performance period. Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the "Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7)" to evaluate use of guideline-recommended antihypertensive medications. Assessing use of guideline-recommended medications included collecting information about the patient's compelling conditions (e.g., diabetes mellitus) as well as allergies and refusals to antihypertensive medications.

Secondary Outcome Measures :

Colorectal Cancer (CRC) Screening [ Time Frame: Baseline period (August - November 2007) ]
This measure reports the proportion of patients who had at least one of four CRC screens in the appropriate timeframe for the first performance period (baseline). Appropriate CRC screens consisted of at least one of the following: 1) fecal occult blood test every year; 2) barium enema every five years; 3) flexible sigmoidoscopy every five years; 4) colonoscopy every ten years. We did not measure the pre-specified post washout period results for this secondary outcome. The pre-specified post washout period results were not to be measured if the final intervention period results were not significant.
Colorectal Cancer (CRC) Screening [ Time Frame: Final intervention period (April-July 2009) ]
This measure reports the proportion of patients who had at least one of four CRC screens in the appropriate timeframe for the fifth and final intervention performance period. Appropriate CRC screens consisted of at least one of the following: 1) fecal occult blood test every year; 2) barium enema every five years; 3) flexible sigmoidoscopy every five years; 4) colonoscopy every ten years. We did not measure the pre-specified post washout period results for this secondary outcome. The pre-specified post washout period results were not to be measured if the final intervention period results were not significant.
Low-density Lipoprotein (LDL) Cholesterol Levels [ Time Frame: Baseline period (August-November 2007) ]
This measure reports the proportion of patients who had LDL control (LDL cholesterol < 100) for the first performance period (baseline). We did not measure the pre-specified post washout period results for this secondary outcome. The pre-specified post washout period results were not to be measured if the final intervention period results were not significant.
Low-density Lipoprotein (LDL) Cholesterol Levels [ Time Frame: Final intervention period (April-July 2009) ]
This measure reports the proportion of patients who had LDL control (LDL cholesterol < 100) for the fifth and final intervention performance period. We did not measure the pre-specified post washout period results for this secondary outcome. The pre-specified post washout period results were not to be measured if the final intervention period results were not significant.
Hemoglobin (Hb) A1c Levels [ Time Frame: Baseline period (August-November 2007) ]
This measure reports the proportion of patients with (Hb)A1c control ((Hb)A1c ≤ 9%) for the first performance period (baseline). We did not measure the pre-specified post washout period results for this secondary outcome. The pre-specified post washout period results were not to be measured if the final intervention period results were not significant.
Hemoglobin (Hb) A1c Levels [ Time Frame: Final intervention period (April-July 2009) ]
This measure reports the proportion of patients with (Hb)A1c control ((Hb)A1c ≤ 9%) for the fifth and final intervention performance period. We did not measure the pre-specified post washout period results for this secondary outcome. The pre-specified post washout period results were not to be measured if the final intervention period results were not significant.
Beta Blocker Use [ Time Frame: Baseline period (August - November 2007) ]
This measure reports the proportion of patients with beta blocker use at the time of the index visit for the first performance period (baseline). We did not measure the pre-specified post washout period results for this secondary outcome. The pre-specified post washout period results were not to be measured if the final intervention period results were not significant.
Beta Blocker Use [ Time Frame: Final intervention period (April-July 2009) ]
This measure reports the proportion of patients with beta blocker use at the time of the index visit for the fifth and final intervention performance period. We did not measure the pre-specified post washout period results for this secondary outcome. The pre-specified post washout period results were not to be measured if the final intervention period results were not significant

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Study participants had to be full-time primary care physicians employed by the Veterans Health Administration (VA) at one of the 12 VA hospitals that participated in the study.

We defined a full-time primary care physician as spending at least 0.60 full-time equivalent (FTE) delivering patient care services in the primary care setting or having a panel size of at least 500 patients at the time of study arm randomization. The primary care settings included internal medicine, primary care medical clinics, and women's health care clinics. The trial did not actively recruit patients into the study. This study retrospectively reviewed a random sample of health records of eligible patients that had clinical encounters with the physician participants.

Exclusion Criteria:

The study did not include VA physicians that were trainees.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00302718

Locations

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United States, Alabama
VA Medical Center, Birmingham
Birmingham, Alabama, United States, 35233
United States, Connecticut
VA Connecticut Health Care System (Newington)
Newington, Connecticut, United States, 06111
United States, Georgia
VA Medical Center, Augusta
Augusta, Georgia, United States, 30904
United States, Massachusetts
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, United States, 02130
United States, Michigan
John D. Dingell VA Medical Center, Detroit
Detroit, Michigan, United States, 48201
Aleda E. Lutz VA Medical Center
Saginaw, Michigan, United States, 48602
United States, Minnesota
VA Medical Center, Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, Mississippi
G.V. (Sonny) Montgomery VA Medical Center, Jackson
Jackson, Mississippi, United States, 39216
United States, Oklahoma
VA Medical Center, Oklahoma City
Oklahoma City, Oklahoma, United States, 73104
United States, Rhode Island
VA Medical Center, Providence
Providence, Rhode Island, United States, 02908
United States, South Carolina
Ralph H Johnson VA Medical Center, Charleston
Charleston, South Carolina, United States, 29401-5799
United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030

Sponsors and Collaborators

VA Office of Research and Development

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

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Principal Investigator:	Laura A. Petersen, MD MPH	Michael E. DeBakey VA Medical Center, Houston, TX

More Information

Publications of Results:

Petersen LA, Simpson K, Pietz K, Urech TH, Hysong SJ, Profit J, Conrad DA, Dudley RA, Woodard LD. Effects of individual physician-level and practice-level financial incentives on hypertension care: a randomized trial. JAMA. 2013 Sep 11;310(10):1042-50. doi: 10.1001/jama.2013.276303.

Hysong SJ, Simpson K, Pietz K, SoRelle R, Broussard Smitham K, Petersen LA. Financial incentives and physician commitment to guideline-recommended hypertension management. Am J Manag Care. 2012 Oct 1;18(10):e378-91.

Petersen LA, Woodard LD, Urech TH. Financial incentives to control hypertension in patients--reply. JAMA. 2014 Jan 15;311(3):303-4. doi: 10.1001/jama.2013.284315. No abstract available.

Woodard LD, Landrum CR, Urech TH, Wang D, Virani SS, Petersen LA. Impact of clinical complexity on the quality of diabetes care. Am J Manag Care. 2012 Sep;18(9):508-14.

Petersen LA, Simpson K, Sorelle R, Urech T, Chitwood SS. How variability in the institutional review board review process affects minimal-risk multisite health services research. Ann Intern Med. 2012 May 15;156(10):728-35. doi: 10.7326/0003-4819-156-10-201205150-00011.

Woodard LD, Urech T, Landrum CR, Wang D, Petersen LA. Impact of comorbidity type on measures of quality for diabetes care. Med Care. 2011 Jun;49(6):605-10. doi: 10.1097/MLR.0b013e31820f0ed0.

Virani SS, Steinberg L, Murray T, Negi S, Nambi V, Woodard LD, Bozkurt B, Petersen LA, Ballantyne CM. Barriers to non-HDL cholesterol goal attainment by providers. Am J Med. 2011 Sep;124(9):876-80.e2. doi: 10.1016/j.amjmed.2011.02.012.

Petersen LA, Urech T, Simpson K, Pietz K, Hysong SJ, Profit J, Conrad D, Dudley RA, Lutschg MZ, Petzel R, Woodard LD. Design, rationale, and baseline characteristics of a cluster randomized controlled trial of pay for performance for hypertension treatment: study protocol. Implement Sci. 2011 Oct 3;6:114. doi: 10.1186/1748-5908-6-114.

Petersen LA. Pay for performance in myocardial infarction: are we reaping the rewards? Nat Clin Pract Cardiovasc Med. 2008 Mar;5(3):134-5. doi: 10.1038/ncpcardio1069. Epub 2007 Dec 4. No abstract available.

Van Swol MA. Does pay-for-performance improve the quality of health care? Ann Intern Med. 2007 Apr 3;146(7):538; author reply 538-9. doi: 10.7326/0003-4819-146-7-200704030-00015. No abstract available.

Petersen LA, Urech TH, Byrne MM, Pietz K. Do financial incentives in a globally budgeted healthcare payment system produce changes in the way patients are categorized? A five-year study. Am J Manag Care. 2007 Sep;13(9):513-22.

Petersen LA, Simpson K, Urech T, Woodard L, Hysong S, Dudley RA. Do financial incentives to health care providers generate greater interest in adhering to performance measures than audit and feedback alone. Journal of general internal medicine. 2009 Apr 1; 24(S1):S58-S59.

Petersen LA, Woodard LD, Henderson LM, Urech TH, Pietz K. Will hypertension performance measures used for pay-for-performance programs penalize those who care for medically complex patients? Circulation. 2009 Jun 16;119(23):2978-85. doi: 10.1161/CIRCULATIONAHA.108.836544. Epub 2009 Jun 1.

Woodard LD, Petersen LA. Improving the performance of performance measurement. J Gen Intern Med. 2010 Feb;25(2):100-1. doi: 10.1007/s11606-009-1198-z. No abstract available.

Petersen LA, Woodard LD, Urech T, Daw C, Sookanan S. Does pay-for-performance improve the quality of health care? Ann Intern Med. 2006 Aug 15;145(4):265-72. doi: 10.7326/0003-4819-145-4-200608150-00006.

Hysong SJ, Kell HJ, Petersen LA, Campbell BA, Trautner BW. Theory-based and evidence-based design of audit and feedback programmes: examples from two clinical intervention studies. BMJ Qual Saf. 2017 Apr;26(4):323-334. doi: 10.1136/bmjqs-2015-004796. Epub 2016 Jun 10.

Petersen LA, Ramos KS, Pietz K, Woodard LD. Impact of a Pay-for-Performance Program on Care for Black Patients with Hypertension: Important Answers in the Era of the Affordable Care Act. Health Serv Res. 2017 Jun;52(3):1138-1155. doi: 10.1111/1475-6773.12517. Epub 2016 Jun 22.

Hysong SJ, SoRelle R, Broussard Smitham K, Petersen LA. Reports of unintended consequences of financial incentives to improve management of hypertension. PLoS One. 2017 Sep 21;12(9):e0184856. doi: 10.1371/journal.pone.0184856. eCollection 2017.

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Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT00302718
Other Study ID Numbers:	IIR 04-349 R01HL079173 ( U.S. NIH Grant/Contract )
First Posted:	March 14, 2006 Key Record Dates
Results First Posted:	December 15, 2014
Last Update Posted:	January 30, 2019
Last Verified:	January 2019

Keywords provided by VA Office of Research and Development:


Physician Incentive Plan Quality of Health Care Reimbursement, Incentive	Randomized Controlled Trial Physicians Reward

Additional relevant MeSH terms:

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Hypertension Vascular Diseases Cardiovascular Diseases

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